New Polymeric Once-Daily Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Pooled Phase 3 Pediatric Analysis

June 2020 | Volume 19 | Issue 6 | Original Article | 602 | Copyright © June 2020

Published online May 8, 2020

Lawrence F. Eichenfield , Emil A. Tanghetti , Eric Guenin , Gina Martin , Radhakrishnan Pillai

ªDepartments of Dermatology and Pediatrics; University of California, San Diego School of Medicine and Rady Children's Hospital, San Diego, CA bCenter for Dermatology and Laser Surgery, Sacramento, CA cOrtho Dermatologics*, Bridgewater, NJ dBausch Health US, LLC*, Petaluma, CA *Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.

Background: Acne vulgaris affects approximately 85% of adolescents. Topical tazarotene is efficacious and safe for acne treatment but irritation limits its use. The objective was to evaluate efficacy, safety, and tolerability of a new tazarotene 0.045% lotion formulation in patients aged 10-13 and 14-17 years with moderate-to-severe acne.
Methods: In two phase 3, double-blind, vehicle-controlled 12-week studies, patients with moderate-to-severe acne (N=1,614) were randomized (1:1) to receive tazarotene 0.045% lotion or vehicle once-daily. Efficacy assessments included changes from baseline in inflammatory/noninflammatory lesions and treatment success (≥2-grade reduction in Evaluator's Global Severity Score [EGSS] and a clear/almost clear score). Quality of life (QoL) and adverse events (AEs) were also assessed.
Results: Patients aged 10-13 years (n=136) and 14-17 years (n=548) were pooled. At week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were significantly greater with tazarotene versus vehicle in both age groups (least-squares mean inflammatory 10-13 years: -55.6 vs -37.0%; 14-17 years: -53.3 vs -41.2%; noninflammatory 10-13 years: -47.7 vs -28.2%; 14-17 years: -52.7 vs -32.9%; P<0.01 all). More patients achieved treatment success with tazarotene versus vehicle in both age groups (P<0.05, both). There were no significant differences between tazarotene-treated age groups in lesion counts or treatment success. Acne-QoL scores at week 12 in both age groups were numerically improved in most domains with tazarotene 0.045% lotion versus vehicle. Most treatment-emergent AEs with tazarotene or vehicle were of mild or moderate severity in both age groups.
Conclusions: Tazarotene 0.045% lotion was efficacious and well tolerated in pediatric patients with moderate-to-severe acne.

J Drugs Dermatol. 2020;19(6): doi:10.36849/JDD.2020.4959


Acne is one of the most common skin diseases1,2 particularly in adolescence, affecting approximately 85% of adolescents and young adults.2 Additionally, acne is increasingly occurring earlier in life, with a younger age associated with greater symptom severity.3 Acne occurs in adolescence due to increases in androgen levels in puberty, which lead to increased sebum production and follicular occlusion, C. acnes bacterium proliferation, and release of proinflammatory factors in the skin.4-6 Recent research reveals that inflammation is a crucial feature of the disease process.7

Acne can confer significant physical and psychological morbidity and diminished quality of life (QoL)8,9 with permanent scarring, reduced self-esteem, depression, or anxiety.2,10 Young patients may be difficult to treat as they tend to be less adherent to treatments11 and may be more susceptible to cutaneous irritation.12

Topical retinoids, such as tazarotene, have anti-inflammatory and comedolytic properties and are a mainstay of topical acne treatment.13 Efficacy, safety, and tolerability of retinoids are well documented for inflammatory and noninflammatory acne. Studies have consistently shown reductions in lesion numbers, significant improvement in acne severity/visible appearance of acne, and prevention of new acne lesion development by inhibiting microcomedone formation.13-15 However, dose-dependent irritation, dryness, and erythema have limited retinoid use.2 The use of moisturizers before the application of tazarotene 0.1% cream has demonstrated enhanced tolerability without altering efficacy, though need for a topical medication with lower irritability remains.16